FDA recall Z-2355-2019

Product

Norm-O-Temp model 111Z

Reason for recall

The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.

Distribution

Ship-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore

Key facts

Status

Terminated

Initiation date

2019-06-20

Report date

2019-09-11

Termination date

2020-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2355-2019